Using his new platform as chair of the U.S. Senate Health, Education, Labor and Pensions Committee, Sen. Bernie Sanders (I-Vt.) is again pushing the Biden administration to reinstate, and strengthen, a “reasonable pricing clause” in all future research agreements involving government agencies, especially those funding drug R&D.
Hookipa Pharma Inc. is looking to raise about $50 million in a public offering to further advance its lead immunotherapy candidate, HB-200, into a pivotal phase III trial in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) for the first-line treatment of recurrent or metastatic head and neck cancer associated with human papillomavirus (HPV) 16.
With much-awaited readouts from their broad oncology-focused collaboration due later this year, Arcus Biosciences Inc. and Gilead Sciences Inc. have decided to expand efforts into the inflammatory disease space via an early stage research agreement that could be worth as much as $1 billion. Terms include a $35 million up-front payment to Arcus, which is making its first move beyond oncology.
The U.S. government’s attempts to enforce its ownership of biopharma intellectual property got a setback May 9 when a six-member federal jury in Delaware determined that Gilead Sciences Inc. did not infringe government patents claiming pre-exposure prophylaxis (PrEP) use of Gilead’s HIV drugs, Truvada and Descovy, both of which combine emtricitabine and tenofovir.
While the U.S. continues to call out other countries for weak enforcement of intellectual property rights, trade secret theft and forced technology transfers in the life sciences sector, some companies in the sector claim similar things are happening in the U.S. In its 2023 Special 301 Report, released April 26, the Office of the U.S. Trade Representative (USTR) noted “the growing need for trading partners to provide effective protection and enforcement of trade secrets.”
Gilead Sciences Inc. has divulged thienopyrrole compounds acting as Toll-like receptor 7 (TLR7) and/or TLR8 antagonists reported to be useful for the treatment of systemic lupus erythematosus, cutaneous lupus erythematosus, lupus nephritis and inflammatory disorders, among others.
Gilead Sciences Inc. has exercised its option to exclusively license Nurix Therapeutics Inc.'s investigational targeted protein degrader molecule NX-0479, now designated GS-6791. This bivalent degrader is the first development candidate resulting from the companies' collaboration to discover, develop and commercialize up to five innovative targeted protein degradation therapies.
Citing clinical trial data backed by real-world data, members of the U.S. FDA’s Antimicrobial Drugs Advisory Committee voted overwhelmingly, 16-1, March 16 that the overall benefit-risk assessment is favorable for the use of Pfizer Inc.’s Paxlovid to treat mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
Despite the new Medicare inflation rebate, the U.S. price of 27 Part B drugs grew faster than inflation in the last quarter of 2022, triggering the new rebate provision in the Inflation Reduction Act. The manufacturers of those single-source drugs will be billed for the rebates in 2025, but Medicare beneficiaries should see a drop in their coinsurance for those drugs, for the next quarter at least. According to the Biden administration, the decrease in out-of-pocket costs for those drugs will range from $2 to as much as $390 per average dose from April 1 through June 30.
The U.S. Court of Appeals for the Federal Circuit once again delved into genus claims as it affirmed Gilead Sciences Inc.’s win in its inter partes review (IPR) challenge of several claims in a patent held by the University of Minnesota.
